Pfizer/BioNTech say data shows COVID-19 vaccine safe and protective in kids

USA – Pfizer Inc and BioNTech SE have said their COVID-19 vaccine induced a robust immune response in 5 to 11-year-olds, and they plan to ask for authorization to use the vaccine in children in that age range in the United States, Europe, and elsewhere as soon as possible. The companies said the vaccine generated an immune response in the 5-to-11-year-olds in their Phase II/III clinical trial that matched what they had previously observed in 16-to-25-year-olds. The safety profile was also generally comparable to the older age group, they said.…

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Glenmark concludes post marketing surveillance (PMS) study on Favipiravir

INDIA – Glenmark Pharmaceuticals, a research-led, global integrated pharmaceutical company, today announced the successful completion of its Post Marketing Surveillance (PMS) study on Favipiravir in India. The study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID-19 patients, Glenmark said in a statement. Results showed no new safety signals or concerns with the use of Favipiravir, and already-known side effects like weakness, gastritis, diarrhea, vomiting among others were found to be mild in nature. The time for fever resolution was 4 days,…

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Granules India and Jubilant Cadista recall pharmaceutical products from US market

INDIA – Generic drug makers Granules India and Jubilant Cadista are recalling different products in the US, the world’s largest market for medicines, for different reasons. As per the latest Enforcement Report by US Food and Drug Administration (USFDA), the US-based unit of Granules India is recalling a batch of Naproxen Sodium tablets, a non-steroidal anti-inflammatory drug used to treat pain, menstrual cramps, inflammatory diseases such as rheumatoid arthritis, gout and fever. According to USFDA, the company’s US-based unit is recalling the affected lot due to “Current Good Manufacturing Practice…

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WHO partners UN in curbing deaths and diseases driven by environmental risk factors

SWITZERLAND – WHO, UNDP, UNEP and UNICEF have partnered to create a new compendium of 500 actions aimed at reducing death and diseases driven by environmental risk factors, the first such resource to unite this expertise from across the UN. Environmental pollution and other environmental risks cause 24 per cent of deaths through, for example, heart disease, stroke, poisonings, traffic accidents, and others. This toll could be substantially reduced – even eliminated – through bold preventive action at national, regional, local and sector-specific levels. The repository presents actions and recommendations…

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Experts call for reduced use of antimicrobial drugs in global food systems

KENYA – The Global Leaders Group on Antimicrobial Resistance has called upon all countries to significantly reduce the levels of antimicrobial drugs used in global food systems. This includes stopping the use of medically important antimicrobial drugs to promote growth in healthy animals and using antimicrobial drugs more responsibly overall. The call comes ahead of the UN Food Systems Summit which takes place in New York on 23 September 2021 where countries will discuss ways to transform global food systems. The Global Leaders Group on Antimicrobial Resistance includes heads of…

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GlaxoSmithKline, SK bioscience start final trial of COVID-19 jab

BRITAIN – British drugs giant GlaxoSmithKline and South Korean peer SK bioscience have announced the commencement of final stage trials of a Covid-19 jab after positive early results. The vaccine is facing a Phase 3 clinical trial to assess its safety and immunogenicity when compared with AstraZeneca’s Covid-19 vaccine, the two companies said in a joint statement. GSK is still trailing in the wake of Anglo-Swedish rival AstraZeneca, which rapidly developed a successful jab alongside Oxford University despite having little prior experience in vaccine development. The new jab combines SK…

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Johnson & Johnson’s HIV vaccine fails mid-stage study in Africa

AFRICA – Johnson & Johnson (JNJ.N) has said its experimental vaccine failed to provide enough protection against HIV in sub-Saharan Africa to young women who are at high risk of being infected. The mid-stage trial failure highlights the challenges of vaccine development, especially for HIV or human immunodeficiency virus, which has no approved vaccines. “HIV is a unique and complex virus that has long posed unprecedented challenges for vaccine development because of its ability to attack, hijack and evade the human immune system,” Paul Stoffels, J&J’s chief scientific officer, said…

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Dr Reddy’s, Zydus recall products in US market as Bharat seeks out vaccine partners

USA – Leading drug makers Dr Reddy’s Laboratories and Zydus Pharma are recalling bottles of a product each, in the US market, for different reasons, according to the latest report of the US health regulator. Dr Reddy’s Laboratories, Inc, the US arm of Dr Reddy’s Laboratories, is recalling 37,560 bottles of Tizanidine HCl tablets, USP 4 mg, the latest enforcement report by the US Food and Drug Administration (USFDA) said. The tablets are manufactured by Dr Reddy’s Laboratories Ltd at its Srikakulam facility, it added. They are used to treat…

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Japan suspends 1.6 million doses of Moderna vaccine after contamination reports

JAPAN – Japan has suspended the use of 1.63 million doses of Moderna Inc’s COVID-19 vaccine, more than a week after the domestic distributor received reports of contaminants in some vials. Both Japan and Moderna said no safety or efficacy issues had been identified and the suspension was just a precaution. “Moderna confirms having been notified of cases of particulate matter being seen in drug product vials of its COVID-19 vaccine,” the U.S. vaccine maker said in a statement, adding it put the lot in question and two adjacent lots…

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Johnson & Johnson seeks to conduct COVID-19 vaccine trial in Indian adolescents

INDIA – US pharma giant Johnson & Johnson has submitted an application to India’s Central Drugs Standard Control Organization (CDSCO) seeking permission to conduct clinical trials of its single shot Janssen vaccine against Covid-19 on adolescents aged 12-17 years. Conducting vaccine clinical trials among adolescents is imperative to achieve herd immunity against the Coronavirus, J&J said in an emailed statement. J&J’s one-shot vaccine has been found to have efficacy of 85.4% against severe disease and 93.1% against hospitalization. The U.S. pharma giant had received emergency use approval for its single-dose…

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